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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Telethermographic, Infrared
510(k) Number K800491
Device Name GRAPHIC STRESS TELETHERMOMETRY
Applicant
Gst Laboratories of Ca, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Gst Laboratories of Ca, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number884.2980
Classification Product Code
IYM  
Date Received03/04/1980
Decision Date 03/04/1980
Decision SE - Postmarket Surveillance Required (SESP)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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